Conservative Treatment of Distal Radius Fracture in Elderly in Randomized Controlled Trial

Comparison of Volar-flexion, Ulnar-deviation and Functional Position Cast Immobilization in the Non-operative Treatment of Distal Radius Fracture in Elderly Patients: a Pragmatic Randomized Controlled Trial

There is no consensus about the best conservative treatment for patients with dorsally displaced distal radius fractures. The previous studies that have examined the most valid method for cast immobilization have lacked uniform and patient-rated outcome measures, proper randomization and sufficient study population. The aim of this study is to compare functional position cast to flexion-ulnar -deviation with dorsally displaced distal radius fractures in patients aged 65 years or older. The conservative treatment is performed in clinical practice by various health care professionals with different techniques of reduction which are not limited to any specific technique in this pragmatic, randomized controlled trial.

Study Overview

• Status: Completed
• Conditions: Distal Radius Fracture; Colles' Fracture
• Intervention / Treatment: Other: Flexion-ulnar cast; Other: Functional cast

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Jyväskylä, Finland
    • Central Finland Central Hospital
  • Pori, Finland
    • Satakunta Central Hospital
  • Tampere, Finland
    • Tampere Univeristy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Low energy intra- or extra-articular dorsal primarily stable, reducible DRF within 3 cm of the radiocarpal joint diagnosed with lateral and posterior-anterior radiographs in ER
• Physician on-call (general practitioner, acute physician, orthopedic resident, orthopedic consult) thinks patient could be appropriate for non-operative treatment

Exclusion Criteria:

• Operative treatment
• Refuse to participate the study
• Open fracture more than Gustilo 1 gradus
• Age under 65 years
• Chauffeure's or Barton´s fracture
• Smith´s fracture (volar angulation of the fracture)
• Does not understand written and spoken guidance in local languages
• Pathological fracture or previous fracture in the same wrist, forearm or elbow

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm 1; Conservative treatment chosen by physician on-call for dorsally displaced radius fracture.	Other: Flexion-ulnar cast; The group will be treated with closed reduction and flexion-ulnar deviation position cast. This will take place under local anaesthesia by means of local infiltration commonly used in Finland. There is no preferable method for performing the reduction. Additional radiographs will be taken to verify the success of the reduction one week after the reduction and after two and five weeks of casting if treating health care professional it requires. The cast will be disposed after 5 weeks.; Other Names: Conservative treatment
Other: Arm 2; Conservative treatment chosen by physician on-call for dorsally displaced radius fracture.	Other: Functional cast; The group will be treated with closed reduction and functional position cast. This will take place under local anaesthesia by means of local infiltration commonly used in Finland. There is no preferable method for performing the reduction. Additional radiographs will be taken to verify the success of the reduction one week after the reduction and after two and five weeks of casting if treating health care professional it requires. The cast will be disposed after 5 weeks.; Other Names: Conservative treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Rated Wrist Evaluation (PRWE) measure is the primary outcome measure of wrist pain and disability in the study	The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists three subscales: Pain, Function and Cosmetics.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability of the wrist measured with the Disability of the Arm, Shoulder and Hand (QuickDASH) questionnaire.	The QuickDASH is self-reported questionnaire and shortened version of DASH outcome measure to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb in 11 dimensions in 1-5 scale.	2 years
Quality of life measured with the 15-D.	The 15D is a validated, generic, self-administered instrument for assessing the health related quality of life among adults. It combines the advantages of a preference-based and single index measure on a 0-1 scale.	2 years
Pain measured in Visual Analogue Scale (VAS).	The VAS is derived by health care professional question of pain in scale 0 to 10 in which 0 implies no pain and 10 the worst possible pain.	Baseline, 3 months, 1 year, 2 years
Range of motion (ROM) is measured with a goniometer	The ROM of the wrist is measured on both hands with a handheld goniometer in degrees.	3 months
Grip strength is measured with a dynamometer	Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in percentage of the uninjured side.	3 months
The pain catastrophizing scale (PCS) is measured with a self-administered questionnaire.	The PCS is designed to measure person's willingness to catastrophize the pain while they are experiencing it. In the questionnaire patients answer questions about how they feel and think when they are in pain and it can be taken while they are not experiencing pain.	2 years

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Central Finland Hospital District; Satakunta Central Hospital
• Investigators: Study Director: Ville Mattila, MD, Professor, Tampere Univeristy Hospital; Principal Investigator: Antti Launonen, MD, PhD, Tampere University Hospital; Study Chair: Aleksi Reito, MD, PhD, Central Finland Central Hospital; Study Chair: Juha Kukkonen, MD, PhD, Satakunta Central Hospital; Study Chair: Minna Laitinen, Adjacent prof, Tampere University Hospital

Publications and helpful links

General Publications

• Raittio L, Launonen AP, Hevonkorpi T, Luokkala T, Kukkonen J, Reito A, Laitinen MK, Mattila VM. Two casting methods compared in patients with Colles' fracture: A pragmatic, randomized controlled trial. PLoS One. 2020 May 29;15(5):e0232153. doi: 10.1371/journal.pone.0232153. eCollection 2020.
• Raittio L, Launonen A, Hevonkorpi T, Luokkala T, Kukkonen J, Reito A, Sumrein B, Laitinen M, Mattila VM. Comparison of volar-flexion, ulnar-deviation and functional position cast immobilization in the non-operative treatment of distal radius fracture in elderly patients: a pragmatic randomized controlled trial study protocol. BMC Musculoskelet Disord. 2017 Sep 18;18(1):401. doi: 10.1186/s12891-017-1759-y.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: August 22, 2016
• First Submitted That Met QC Criteria: September 4, 2016
• First Posted (Estimate): September 9, 2016

Study Record Updates

• Last Update Posted (Actual): May 22, 2018
• Last Update Submitted That Met QC Criteria: May 18, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: rehabilitation; wrist fracture; non-operative; colles fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations; Arm Injuries; Forearm Injuries; Fracture Dislocation; Fractures, Bone; Radius Fractures; Colles' Fracture; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Cysteine Proteinase Inhibitors; Calpastatin
• Other Study ID Numbers: R16035